Reducing Chronic Pain After Lung Surgery: A Trial of Limiting NSAIDs During Recovery

NCT07108582 | Not Yet Recruiting Phase 3

• 1 other identifier: 9797
• Study Type: interventional
• Target: 270
• Locations: 0 countries
• Sites: N/A

Brief Summary

Chronic postoperative pain (CPOP) after video-assisted thoracic surgery (VATS) is severe because it results from lesions at multiple levels: incisions, pulmonary or nerve contusions. PCOD is defined by the IASP (International Association for the Study of Pain) as persistent pain 3 months after surgery. It affects around 30% of patients and significantly impairs recovery and quality of life. One of the many factors contributing to the appearance of PCOD is acute perioperative pain. To combat this acute pain and limit postoperative chronic pain, a multimodal analgesia strategy is necessary, particularly during thoracic surgery with a high nociceptive potential. This type of protocol will enable acute pain to be controlled by various means: tier 1 analgesics (paracetamol, NSAIDs), tier 2 (nefopam, tramadol) and tier 3 (opioid drugs), locoregional anaesthesia, co-analgesics and non-medicinal techniques. Thus, avoiding NSAIDs will have no effect on the increase in acute pain. A study of the impact of eliminating NSAIDs on chronic pain can therefore be carried out without increasing patients' acute pain. A team from McGill University, Montreal, Canada, recently discovered a paradoxical effect of anti-inflammatory drugs on the chronicisation of pain. They demonstrated that although anti-inflammatory drugs initially had an acute analgesic effect, they induced neutrophil depletion and a drastic change in the transcriptome postoperatively, leading to more chronic pain. These studies highlight the fact that although NSAIDs have an acute analgesic effect, their use could ultimately prove counterproductive by encouraging the development of CD. However, to date there are no studies demonstrating that a minimum dose or duration of NSAID treatment leads to the development of DCPO. On the basis of these results, it is justified to assess the impact of NSAIDs widely used in routine care in thoracic surgery on the development of DCPO. In order to improve pain management in the intraoperative phase, nociception monitoring is necessary. The PMD200® (Medasense Biometrics Ltd.) is the most recent monitor designed for this purpose, having demonstrated sensitivity and specificity in detecting nociceptive stimuli under general anaesthesia (4). It will make it possible to guide the administration of analgesic agents by displaying a nociception index (NOL index). Our hypothesis, based on this work, is that anti-inflammatory drugs, despite having an acute analgesic effect, could promote the development of DCPO after VATS.

Conditions

Chronic Post-operative Pain

Outcome Measures

Primary Outcomes (1)

• Assessment of Postoperative Pain at 3 Months Using a Numerical Rating Scale (NRS)

  3 months post-op

Secondary Outcomes (12)

• Assessment of Maximum Pain Scores at Rest and During Mobilisation Using a Numerical Rating Scale

  Days 0, 1, 3, 1 month and 3 months post-op

• Assessment of Neuropathic Pain Using the DN4 Questionnaire

  Days 1, 3, 1 month and 3 months post-op

• Cumulative Morphine Equivalent Dose of Opioids Administered Intraoperatively

  Days 1, 3, 1 month and 3 months post-op

• Length of Hospital Stay in Both Patient Groups

  up to 3 months post-op

• QoR-15 Score

  1 month and 3 months post-op

Study Arms (2)

AINS+

ACTIVE COMPARATOR

* 100 mg ketoprofen LP orally administered 30 minutes before surgery, * 50 mg ketoprofen intravenously at the end of surgery * then 100 mg ketoprofen LP PO twice a day for 7 days following surgery

Drug: protocol for administering NSAIDs already used in routine care

AINS-

EXPERIMENTAL

no NSAID but a placebo with identical galenic formulations to maintain blindness at all times during participation in the study

Drug: no NSAID

Interventions

no NSAID DRUG

no NSAID but a placebo with identical galenic formulations to maintain blindness at all times during participation in the study

AINS-

protocol for administering NSAIDs already used in routine care DRUG

* 100 mg ketoprofen LP orally administered 30 minutes before surgery, * 50 mg ketoprofen intravenously at the end of surgery * then 100 mg ketoprofen LP PO twice a day for 7 days following surgery

AINS+

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 18 to 75
• Patients scheduled for video-assisted thoracic surgery
• Able to give informed consent to participate in the study
• Affiliated to a social health insurance scheme

You may not qualify if:

• History of renal insufficiency or chronic pain
• Surgical contraindications to NSAIDs (talc surgery)
• Contraindications to NSAIDs described in the VIDAL RCP (renal insufficiency, allergy, etc.)
• History of chronic use of opioids or anti-inflammatories (continuous use for more than 3 months in the year preceding surgery)
• Urgent surgery;
• Participation in another interventional drug clinical trial.
• Impossibility of giving the subject informed information in the event of difficulties in understanding the subject
• Incapacitated subject (subject to a legal protection measure: safeguard of justice, curatorship, guardianship, future protection mandate, family habilitation)
• Pregnant or breast-feeding

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Clinical Protocols

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Central Study Contacts

Walid OULEHRI

CONTACT

+33 3 69 55 12 71; walid.oulehri@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: phase 3, double-blind, multicentre, placebo-controlled, randomised, parallel-arm trial

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: August 7, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: August 7, 2025

Record last verified: 2025-07